No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation is currently under way.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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It was reported that the pta balloon dilatation catheter was used in a left av graft and was inflated to approximately 18 atm.It was further reported that the balloon was removed from the patient and place in the back table for further use.During preparation, the technologist allegedly identified the fibers of the balloon had unraveled.Reportedly, another pta dilatation balloon was used to complete the procedure.There was no patient injury reported.
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H10: manufacturing review:the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event investigation summary:the device was returned for evaluation.A visual inspection found peeled outer layer from the balloon throughout the length of the balloon.Additionally, fibers were noted to be unraveled from the balloon on the distal cone of the balloon.Fiber disturbance was also noted on the distal end of the balloon.Therefore, the investigation was confirmed for the reported unraveled fibers, as well as for frayed fibers.Additionally, the investigation was confirmed for peeled outer layer.The definitive root cause for the identified fiber issues or outer layer peeling could not be determined based upon the available information.An investigation was currently open to address the outer layer peeling issue.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: g4, d4 (expiration date: 11/2020).
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It was reported that the pta balloon dilatation catheter was used in a left av graft and was inflated to approximately 18 atm.It was further reported that the balloon was removed from the patient and place in the back table for further use.During preparation, the technologist allegedly identified the fibers of the balloon had unraveled.Reportedly, another pta dilatation balloon was used to complete the procedure.There was no patient injury reported.
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